rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older

NCT07762014 | Recruiting Phase 2 DMC

• 3 other identifiers: rBCG-N-RSV 002GR2023-509048-80-012023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. It will also compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years and characterize the cellular immune response against RSV nucleoprotein (N) generated by the rBCG-N-RSV vaccine in adults older than 60 years as compared to the response induced by the conventional BCG.

Conditions

Respiratory Syncytial Virus Infection Prevention; Tuberculosis Prevention

Keywords

Respiratory Syncytial Virus; RSV; Respiratory Syncytial Virus vaccine; Vaccine; Tuberculosis; TB; Tuberculosis vaccine; BCG

Outcome Measures

Primary Outcomes (6)

• Occurrence, intensity, and duration of the local solicited AEs (evolution of the "flare-up") until the generation of the scar

  From vaccination through 180 days post-vaccination

• Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up.

  From vaccination through 180 days post-vaccination

• Occurrence of AEs during the 6-month follow-up duration.

  From vaccination through 180 days post-vaccination

• Alterations to the hemogram and/or biochemical profile at 30- and 180- days post vaccination compared to pre-vaccination profile

  Day 30 and day 180 post-vaccination

• Production of IFN-γ and IL-2 by T cells upon exposure to purified protein derivative (PPD) mycobacterial antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination.

  Day 30 and day 180 post-vaccination

• Production of IFN-γ and IL-2 by T cells upon exposure to recombinant RSV nucleoprotein antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination

  Day 30 and day 180 post-vaccination

Secondary Outcomes (2)

• Presence and titers of serum IgG antibodies against Purified Protein Derived Mycobacterial antigen (PPD) via ELISA

  Day 30 and day 180 post-vaccination

• Presence and titers of serum IgG against RSV nucleoprotein via ELISA.

  Day 30 and day 180 post-vaccination

Other Outcomes (3)

• Cases of symptomatic RSV infection confirmed by RT-qPCR detection in respiratory specimens from 14 days to 6 months after vaccination.

  From day 14 to 6 months post-vaccination

• Cases of hospitalization/intensive care unit admission and/or death in participants with RSV infection confirmed by RT-qPCR in vaccinated subjects from 14 days to 6 months postvaccination

  From day 14 to 6 months post-vaccination

• Increase in the percentage of specific CD4+ and CD8+ T cells that express AIM and memory markers via flow cytometry in the peripheral blood of a subgroup of participants that receive the control and the study vaccine.

  Day 30 and day 180 post-vaccination

Study Arms (2)

rBCG-N-RSV vaccine

EXPERIMENTAL

rBCG-N-RSV is a live-attenuated vaccine of Mycobacterium bovis bacillus Calmette-Guerin (BCG) modified to heterologously and constitutively express the RSV nucleoprotein (N). The clinical formulation with this bacterium has been produced under strict quality and safety standards using current Good Manufacturing Practices (cGMP) in the United States of America (USA). Pharmaceutical form: Lyophilisate for solution for injection Medicinal product characteristics: Immunological Route of administration: Intradermal use Maximum duration of treatment: 1 Day Maximum daily dose allowed: 0.1 Daily dose unit of measure: CFU/ml colony forming unit(s)/millilitre Maximum total dose allowed: 0.1 Total dose unit of measure: CFU/ml colony forming unit(s)/millilitre

Biological: Vaccination with rBCG-N-RSV

Mycobacterium bovis bacillus Calmette-Guerin (BCG)

ACTIVE COMPARATOR

BCG is a cryo-lyophilized vaccine of an attenuated strain of Mycobacterium bovis BCG, used for active immunization against tuberculosis. It is currently administered in numerous countries worldwide according to national immunization plans. Medicinal product characteristics: Immunological Route of administration: Intradermal use Maximum duration of treatment: 1 Day Maximum daily dose allowed: 0.1 Daily dose unit of measure: CFU/ml colony forming unit(s)/millilitre Maximum total dose allowed: 0.1 Total dose unit of measure: CFU/ml colony forming unit(s)/millilitre

Biological: Vaccination with conventional BCG (BCG-WT)

Interventions

Vaccination with rBCG-N-RSV BIOLOGICAL

Intradermal vaccination with rBCG-N-RSV that expresses the N protein of the respiratory syncytial virus (RSV)

rBCG-N-RSV vaccine

Vaccination with conventional BCG (BCG-WT) BIOLOGICAL

Intradermal vaccination with conventional BCG (BCG-WT).

Mycobacterium bovis bacillus Calmette-Guerin (BCG)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed the written informed consent process.
• Males or females, over 60 years of age as of the date of signature of the informed consent form.

You may not qualify if:

• Willingness to comply with study procedures.
• No plans to move to another city in the next 6 months and willing to be contacted by the research team within the study period.
• Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months.
• Agrees to avoid elective surgery during the study.
• Willingness to receive HIV test results.
• Not having received a BCG vaccination within the last 10 years before study vaccination.
• Exlusion Criteria
• Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours.
• Weight less than 50 kg, as well as BMI less than 18.5 or higher than 35 kg/m2.
• History of treatment or current history of active or latent tuberculosis infection.
• History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months.
• Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed).
• Received documented investigational tuberculosis vaccine at any time.
• Unstable hormonal status, i.e. subjects with any change (dose, formulation, or route) in hormone replacement therapies (including levothyroxine, insulin, estrogen, progesterone etc.) in the last 12 weeks.
• History or laboratory evidence of any possible past, present, or future immunodeficiency status, including, but not limited to, any laboratory indication of HIV-1 infection.

Sponsors & Collaborators

• Biothervax SpA: lead
• Pharmassist Ltd: collaborator
• Hellenic Pasteur Institute: collaborator
• Sotiria Thoracic Diseases Hospital of Athens: collaborator

Study Sites (1)

Sotiria Thoracic Diseases Hospital of Athens

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Central Study Contacts

Maria Moukouli

CONTACT

+30 210 6560700; m.moukouli@pharmassist-cro.com

Maria Kiriakaki

CONTACT

+30 210 6560700; m.kiriakaki@pharmassist-cro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 13, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): September 7, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

GR (1)